WO2006134421A2 - Appareil de mesures ameliorees de sphygmo-oxymetrie - Google Patents

Appareil de mesures ameliorees de sphygmo-oxymetrie Download PDF

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Publication number
WO2006134421A2
WO2006134421A2 PCT/IB2005/004122 IB2005004122W WO2006134421A2 WO 2006134421 A2 WO2006134421 A2 WO 2006134421A2 IB 2005004122 W IB2005004122 W IB 2005004122W WO 2006134421 A2 WO2006134421 A2 WO 2006134421A2
Authority
WO
WIPO (PCT)
Prior art keywords
sensor
interior
housing
light
light source
Prior art date
Application number
PCT/IB2005/004122
Other languages
English (en)
Other versions
WO2006134421A3 (fr
Inventor
Bernd Lindner
Martin Eckermann
Thomas Scholl
Steven Gorski
Original Assignee
Envitec-Wismar Gmbh
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Envitec-Wismar Gmbh filed Critical Envitec-Wismar Gmbh
Priority to EP05857996A priority Critical patent/EP1807001A2/fr
Publication of WO2006134421A2 publication Critical patent/WO2006134421A2/fr
Publication of WO2006134421A3 publication Critical patent/WO2006134421A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14552—Details of sensors specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6825—Hand
    • A61B5/6826—Finger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6838—Clamps or clips
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/314—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry with comparison of measurements at specific and non-specific wavelengths
    • G01N2021/3144—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry with comparison of measurements at specific and non-specific wavelengths for oxymetry
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/35—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light

Definitions

  • the present invention relates generally to the measurement of arterial oxygen saturation by non-invasive electro-optical sensing — commonly referred to in practice as pulse oximetry — and more specifically to an apparatus for optimizing electro-optical signals utilized in the measurement.
  • Pulse oximetry utilizes an electro-optical sensor attached to a patient and a monitor that measures the electro-optical signals and calculates patient oxygenation. Because of its simplicity, reliability, and ability to quickly report changes in patient oxygenation status, pulse oximetry measurement has been employed for the past twenty years as a standard of care in critical care monitoring of patients.
  • External or non-invasive pulse oximetry devices typically utilize light transmittance or reflectance technology incorporating a light source and a detector (or sensor) operatively attached to an individual. Light emitted from the light source is passed through the individual's tissue wherein a portion thereof is received by the sensor and analyzed to determine the blood saturation level of the tissue.
  • a portion of the light is received by a photodetector and converted into a current that may be on the order of several to tens of microamperes in magnitude.
  • This relatively small electrical signal is transmitted via a sensor cable (and an extension cable, if necessary) to a monitor, where it is amplified, measured, and interpreted according to the monitor's measurement algorithm(s).
  • oximetry generally relies upon detection and measurement of minute current signals
  • effects related to signal-to-noise limitations should be considered.
  • the operational environment for oximeter devices typically includes other electronic devices nearby, e.g., surgical equipment.
  • Some common techniques used to address signal-to-noise performance include utilization of shielded cables and detectors, and a method of pulsing of the LED' s at a high current (on the order of 40 to 40OmA) for a short duty cycle to temporarily boost the light output and detector signal.
  • a high current on the order of 40 to 40OmA
  • LED intensity levels may gradually decline over the life of the sensor and may lead to an eventual failure of providing usable signal levels.
  • a typical reusable finger clip SpO2 sensor is comprised of a hinged housing made of rigid plastic, which holds flexible pads that contact a patient's skin, e.g., finger.
  • the pads contain optical elements preferably covered with a transparent material, e.g., layer, pane, window; that facilitate measurements through the patient's finger.
  • a transparent material e.g., layer, pane, window
  • One particular finger clip sensor, the Nellcor DS-100A has pads made from a white silicone material, and a clip configuration that is open and permits ambient light to enter the finger from the sides. Ambient light is therefore added to the detector baseline signal, and may in some cases affect the signal measurement quality.
  • the white color of the pads is generally highly reflective in both the red and infrared wavelengths present in the sensor, and assists the reflectance of several internal pathways. As such, utilization of the white pads facilitates the throughput of the generated light signals and generally provides a more efficient transfer of light from the LED to the detector. Referring to FIG. 2, the diagram is illustrative of this feature — showing light exiting the light source and passing through the finger via multiple transmissive, reflective, and scattering paths and entering the detector.
  • the present invention generally provides a sensor device for non-invasively measuring a blood oxygen level of a patient.
  • the sensor device comprises a bi-color pad topology that includes a material having a reflectance and/or transmittance characteristic to light, e.g., light color, that is proximate to a light emitting device, e.g., OPTO device; and another material over the rest of the pad or housing — in the case of a tube-like sensor device — having a relatively less reflectance and/or transmittance characteristic to that of the light color material.
  • a light emitting device e.g., OPTO device
  • This novel configuration simultaneously addresses concerns involving increased light level reception and reduced susceptibility to ambient light and is especially useful in the construction of rubber tube type sensor devices.
  • the senor comprises a housing including an interior surface substantially surrounding an interior and including a first material that ⁇ s substantially non-reflective and/or non-transmissive to light.
  • a light source is affixed to the housing and proximate the interior surface so as to project light within the interior of the housing.
  • a light detector is affixed to the housing and proximate the interior surface.
  • a second material is proximate the light source or the light detector, wherein the second material includes a property that is relatively more reflective, transmissive, or a combination thereof, to light than the first material.
  • a sensor utilized in monitoring patient oxygenation comprises a housing including a material that is substantially non-reflective and/or non-transmissive to light.
  • the housing includes an interior and an interior surface having an opening.
  • An inset housing includes a material that is more reflective and/or transmissive than the housing material and is inlaid within the opening of the interior surface.
  • a light source is substantially surrounded by the inset housing wherein an exposed portion of the light source is proximate the interior surface so as to project light within the interior of the housing.
  • a sensor capable of attachment to a patient for monitoring oxygenation comprises a housing having an interior wall substantially surrounding an interior.
  • the interior wall includes a non-reflective material and an outlet, and is capable of being placed proximate the patient's skin.
  • An inset housing includes a reflective and/or transmissive material and is inlaid within the outlet.
  • a light source is substantially surrounded by the inset housing wherein an exposed portion of the light source is positioned proximate the interior wall so as to project light produced by the light source toward the interior of the housing.
  • a light detector for receiving illuminations of the light source preferably red or infrared — is operatively attached to the housing and proximate the interior.
  • a portion of the interior wall is continuous; and may also include a segment that is coplanar with an interior plane.
  • a segment of the non-reflective material and a segment of the reflective and/or transmissive material are coplanar with the interior plane.
  • a transparent material e.g., layer, pane, window; is positioned between the light source and the interior, and/or between the light detector and the interior.
  • FIG. 1 is perspective drawings of one embodiment of the present invention
  • FIG. 2 is cross-sectional view of a commonly known sensor geometry depicting multiple transmitted, reflected, and scattered paths of light;
  • FIG. 3 is cross-sectional view of a tube type sensor according to one embodiment of the present invention.
  • FIG. 4 is a magnified view of a portion of the tube type sensor shown in FIG. 3;
  • FIG. 5 is cross-sectional view of a clip type sensor according to one embodiment of the present invention.
  • FIG. 6 is a magnified view of a portion of the clip type sensor shown in FIG.
  • FIG. 7 is a perspective view one embodiment of the light source and inset housing of the present invention.
  • FIG. 8 is a cross-section view of FIG. 7;
  • FIGS. 9-12 comparison of R-3512-9 (old type of build) and R-3512-20 (white inset, old ad).
  • FIG. 1 One embodiment of the present invention is shown in FIG. 1 as a sensor device 10 utilized in monitoring patient oxygenation.
  • a sensor device 10 utilized in monitoring patient oxygenation.
  • FIGS. 3-8 several configurations of the sensor 10 are shown to include a housing 12 including an interior surface 24 that may be continuous in at least one direction.
  • the interior surface 24 substantially surrounds an interior 22 and includes a first material that is substantially non-reflective and/or non-transmissive to light.
  • a light source 14 is operatively affixed to the housing 12 and proximate the interior surface 24 so as to project light within the interior 22 of the housing.
  • a light detector is 20 operatively affixed to the housing 12 and proximate the
  • a second material is proximate the light source 14 or the light detector 20, wherein the second material is relatively more reflective, transmissive — or a combination thereof — to light as compared to the first material of the interior surface 24.
  • the light source 14 or detector 20 can be operatively attached to the interior surface 24 wherein the reflective and/or transmissive material is positioned about the light source or detector.
  • the material substantially surrounding the light source 14 and/or detector 20 is reflective primarily in the red (approximately 660nm) and infrared (approximately 880-940nm) regions.
  • FIGS. 5 and 6 is in the form of a soft-tip tube- type sensor surrounding a finger tip
  • the housing 12 is constructed of a flexible, substantially non-reflective and/or transmissive material— preferably dark colored rubber— and includes an interior 22 wherein a patient's tissue, e.g., phalanges, can be placed.
  • An interior surface 24 or wall substantially surrounds the interior 22 and includes an opening 26 or outlet.
  • the sensor 10 shown in FIGS. 5 and 6 includes a shell 28 in the form of a relatively less flexible material, e.g., plastic, that operatively encases the housing 12.
  • the sensor 10 preferably includes a light source 14 — red and/or infrared light — substantially surrounded by an inset housing 16.
  • the inset housing 16 includes a material that is relatively more reflective and/or transmissive to light, e.g., white silicone rubber, than that of the interior surface 24 and is inlaid within the opening 26 or outlet of the interior surface.
  • An exposed portion of the light source 14 is proximate the interior surface 24 so as to project light toward the interior 22 of the housing 12.
  • the inset housing 16 is substantially surrounded by the housing 12 and its non-reflective material that preferably extends at least one millimeter about the perimeter of the light source 14.
  • the white colored material of the inset housing 16 facilitates internal reflections of light near this region as well as the overall light transmission throughput; while at the same time, the darker colored — relatively less reflective and/or transmissive — material of the housing 12 blocks admittance of ambient light.
  • a transparent material 18, e.g., layer or pane, may be positioned proximate the light source 14 to more effectively couple the light near the patient's tissue.
  • a layer of transparent material 18 covers the embedded light source 14 and inset housing 16.
  • a portion of the inset housing 16 and/or the light source 14 intersects a plane 30 coplanar with a portion of the interior surface 24 and protrudes into the interior 22 of the housing 12.
  • the transparent material 18 preferably covers at least a portion of the interior surface 24, the light source 14, and the reflective inset housing 16.
  • the pane of transparent material 18 is proximate the light source 14 and the inset housing 16, and flush — coplanar — with the interior wall 24.
  • the plane 30 adjacent the patient's tissue includes a portion of the non-reflective material of the interior surface 24 and the transparent material 18.
  • the light detector 20 can be configured within an inset housing 16 having a reflective and/or transparent material inlaid within the non-reflective interior surface 24 similar to that proximate the light source 14.
  • the white colored region of the inset housing 16 may be completely surrounded by darker colored material of the housing 12 and/or interior surface 24 as provided by common insert molding techniques and other methods that allow the molded housing or pad to fully enclose the more reflective and/or transmissive material from the rear.
  • portions of the light source 14 and the detector 20 substantially lie within the same plane.
  • a portion of the plane 30 is curvilinear to facilitate placement of the sensor — and that of its light source 14 and/or detector 20 — adjacent the patient's tissue, e.g., finger, toe.
  • tissue e.g., finger
  • the present invention is capable of various configurations — with respect to the housing 12, inset housing 16, light source 14, transparent material 18, plane 30, interior surface 24, and/or the interior 22 — are responsive to particular applications, e.g., reflective technology, and are considered to be within its scope.
  • Comparative measurements of light throughput can be used to assess relative light efficiency. These measurements, sometimes called trans-conductance tests, assess the detector output current at specified DC levels of LED illumination.
  • LED's are illuminated one at a time at a fixed current such as 2OmA DC, and the detector current is recorded for each LED (red and infrared). This may be performed with an empty sensor ("probe off finger” condition), a test subject's finger, or a finger model such as a plastic rod. Perhaps the most meaningful comparative test of light throughput uses a test subject's finger, with the condition that the same finger be used within a short period of time in a similar position on all sensors to be compared.
  • a test subject's finger with the condition that the same finger be used within a short period of time in a similar position on all sensors to be compared.
  • the following comparison of transmittance includes three sensors Al, A2, and B.
  • Sensor Al includes the sensor having a close fit to the finger and the white inset housing of the present invention.
  • Sensor A2 includes the white inset housing of the present invention in a sensor that does not have as close a fit to the finger as Al .
  • Sensor B includes neither the close fit of Al nor the white inset of the present invention.
  • Chart 1 details comparative light efficiency results for the rubber type sensors Al, A2, and B. Transmittance readings provide similar information normalized for LED current as ⁇ A(detector output)/mA(LED current).
  • Chart 1 Transmittance Com arison.
  • Chart 1 illustrates that utilization of the white inset in the sensor — located in the region of the optical devices — can substantially improve sensor light efficiency while simultaneously rejecting ambient light.
  • the sensor is but one component of an oximeter monitoring system
  • signal-to-noise improvements in the sensor may be translated into performance improvements in the system.
  • compromised perfusion i.e., poor arterial blood circulation
  • at a measurement site represents one of the significant challenges to SpO2 monitors, and a modest improvement in signal-to-noise may mean the difference between function and non-function under extreme conditions.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Optics & Photonics (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)

Abstract

L'invention porte sur un appareil de mesure du niveau d'oxygène sanguin d'un patient. Dans une exécution, l'appareil comprend: un logement dont la surface intérieure est revêtue presque entièrement d'un matériau non réfléchissant; une source lumineuse et un détecteur coopérants placés au voisinage de la surface intérieure et émettant et recevant la lumière projetée à l'intérieur du logement; et un matériau meilleur conducteur de la transmission et de la réflectance de la lumière ou de leur combinaison que le matériau non réfléchissant, placé au voisinage de la source lumineuse et du détecteur.
PCT/IB2005/004122 2004-11-05 2005-11-07 Appareil de mesures ameliorees de sphygmo-oxymetrie WO2006134421A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP05857996A EP1807001A2 (fr) 2004-11-05 2005-11-07 Appareil de mesures ameliorees de sphygmo-oxymetrie

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US52277204P 2004-11-05 2004-11-05
US60/522,772 2004-11-05

Publications (2)

Publication Number Publication Date
WO2006134421A2 true WO2006134421A2 (fr) 2006-12-21
WO2006134421A3 WO2006134421A3 (fr) 2007-03-29

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US (1) US7679519B2 (fr)
EP (1) EP1807001A2 (fr)
WO (1) WO2006134421A2 (fr)

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US20060129039A1 (en) 2006-06-15
WO2006134421A3 (fr) 2007-03-29
EP1807001A2 (fr) 2007-07-18
US7679519B2 (en) 2010-03-16

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